CDISC and NORD Partner to Develop Data Standards for Rare Diseases

CDISC and NORD Partner to Develop Data Standards for Rare Diseases

DANBURY, CT and AUSTIN, TX – 22 Apr 2021 – CDISC and the National Organization for Rare Disorders (NORD®) have announced a partnership to develop global data standards for rare diseases. The data standards will be released in a Therapeutic Area User Guide that will be available at no cost on the CDISC website for researchers to leverage in studies to maximize data’s full potential.

According to the FDA, any disease, disorder, illness or condition affecting fewer than 200,000 people in the United States is considered rare. There are approximately 7,000 rare diseases and it’s estimated that 25-30 million Americans have rare diseases. More than 90% of rare diseases have no FDA-approved treatment. Globally, it is estimated that 350 million individuals are impacted by a rare disease.

Therapeutic Area User Guides provide examples and guidance on implementing CDISC standards so that data can be structured effectively and easily analyzed. CDISC Standards drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market for treatments developed based on patient data.

“We are grateful for the opportunity to work with NORD on this much-needed initiative,” said Dave Evans, CDISC President and CEO. “NORD’s support and partnership will allow CDISC to develop standards that facilitate more powerful research, enabling the discovery of new treatments to help patients.”

“We have seen through NORD’s IAMRARE® registry platform the immense value of patient-powered research to serve as a catalyst for the development of rare disease treatments,” said Pamela Gavin, NORD Executive Vice-President and COO. “We believe that by partnering with CDISC, we can help set global data standards that will lead to greater participation in research and fuel a new era of patient-centered innovation.”

To date, CDISC has developed Therapeutic Area User Guides for over 40 disease areas.


CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world.

About the National Organization for Rare Disorders (NORD®)

The National Organization for Rare Disorders (NORD) is the leading independent advocacy organization representing all patients and families affected by rare diseases in the United States. NORD began as a small group of patient advocates that formed a coalition to unify and mobilize support to pass the Orphan Drug Act of 1983. Since then, the organization has led the way in voicing the needs of the rare disease community, driving supportive policies, furthering education, advancing medical research and providing patient and family services for those who need them most. Together with over 330 disease-specific member organizations, more than 15,000 Rare Action Network advocates across all 50 states, and national and global partners, NORD delivers on its mission to improve the lives of those impacted by rare diseases. Visit . 


Ann P. White
Lesli Proffitt Nordstrom